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e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial.
Hum Reprod 2016; 31(5):1046-57HR

Abstract

STUDY QUESTION

Is it feasible to evaluate a personalized e-therapy program (Internet based) for women during fertility treatment aimed to reduce the chance of having clinically relevant symptoms of anxiety and/or depression after unsuccessful assisted reproductive technology (ART) treatment within a randomized controlled trial (RCT)?

STUDY ANSWER

The evaluation of a personalized e-therapy program is feasible, reflected by good acceptability and integration within current guidelines, but adjustments to the e-therapy program and study design of the RCT have to be made to enhance demand, practicality and efficacy.

WHAT IS KNOWN ALREADY

Internet-based interventions are promising in reducing psychological distress, especially when treatment is personalized to specific risk profiles of patients. However in fertility care, the beneficial effects of personalized e-therapy on psychological distress and its implementation in daily clinical care still have to be evaluated.

STUDY DESIGN, SIZE, DURATION

To evaluate the feasibility of a personalized e-therapy program, we conducted a two-arm, parallel group, single-blind feasibility randomized controlled trial with a 1:1 allocation. Feasibility was assessed in terms of demand, acceptability, practicality, implementation, integration and limited efficacy. Women were included between 1 February 2011 and 1 June 2013. Women in the control group received care as usual, whereas women in the intervention group received in addition to their usual care access to a personalized e-therapy program. Women were monitored until 3 months after the start of their first ART cycle.

PARTICIPANTS/MATERIALS, SETTING, METHODS

In a university hospital in the Netherlands women who were screened as at risk for emotional adjustment problems and intended to start their first ART cycle were invited, and of them 120 were randomized. Of these women, 48% in the intervention group were compliant to the intervention. Outcome measures associated with the feasibility to analyse this e-therapy program within an RCT were assessed.

MAIN RESULTS AND THE ROLE OF CHANCE

It is feasible to evaluate a personalized e-therapy program within an RCT. The acceptability was good, as was the integration within current clinical guidelines and care. However, the demand reflected by a participation rate of 44% was low, since most women declined participation because they felt no need for support at that moment. The practicality of the intervention was moderate illustrated by a relatively high dropout rate (30%) due to practical concerns. The intervention was effective, shown by a reduction in the percentage women having clinically relevant symptoms of anxiety and/or depression in the compliant intervention group compared with the control group 3 months after the first ART cycle; risk difference of 24% (95% CI: 2-46%; ITALIC! P = 0.03).

LIMITATIONS, REASONS FOR CAUTION

The large non-participation rate (56%) needs further evaluation. This also could have influenced results on limited efficacy. Barriers for participation could be assessed more in-depth. Moreover, ∼30% dropped out. This percentage is comparable with other e-health studies. Finally, this is a single-centre study. Generalizability could be enlarged by a multi-centre approach.

WIDER IMPLICATIONS OF THE FINDINGS

In clinical fertility care, personalizing an e-therapy program to the patients' risk profile is promising and feasible. However, in future studies, we recommend modification of the study protocol by for example offering the intervention to the preferred moment in the treatment process. Moreover, adjustment of the study protocol tailored to the found barriers and facilitators is needed. When performing a multi-centre consecutive RCT to assess the effectiveness of personalized e-therapy in fertility care, the findings of this study, for example concerning the preferred timing or reasons for non-participation, could be helpful.

STUDY FUNDING/COMPETING INTERESTS

NutsOhra (Study Number 0702-94) funded this study with an unrestricted grant. There were no competing interests.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov NCT 01283607.

TRIAL REGISTRATION DATE

21 January 2011.

DATE OF FIRST PATIENT'S ENROLMENT

February, 2011.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands angelique.vandongen@radboudumc.nl.Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Radboud Institute for Health Sciences, Section Biostatistics, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.Department of Medical Psychology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26965429

Citation

van Dongen, Angelique J C M., et al. "E-Therapy to Reduce Emotional Distress in Women Undergoing Assisted Reproductive Technology (ART): a Feasibility Randomized Controlled Trial." Human Reproduction (Oxford, England), vol. 31, no. 5, 2016, pp. 1046-57.
van Dongen AJ, Nelen WL, IntHout J, et al. E-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial. Hum Reprod. 2016;31(5):1046-57.
van Dongen, A. J., Nelen, W. L., IntHout, J., Kremer, J. A., & Verhaak, C. M. (2016). E-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial. Human Reproduction (Oxford, England), 31(5), pp. 1046-57. doi:10.1093/humrep/dew040.
van Dongen AJ, et al. E-Therapy to Reduce Emotional Distress in Women Undergoing Assisted Reproductive Technology (ART): a Feasibility Randomized Controlled Trial. Hum Reprod. 2016;31(5):1046-57. PubMed PMID: 26965429.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - e-Therapy to reduce emotional distress in women undergoing assisted reproductive technology (ART): a feasibility randomized controlled trial. AU - van Dongen,Angelique J C M, AU - Nelen,Willianne L D M, AU - IntHout,Joanna, AU - Kremer,Jan A M, AU - Verhaak,Christianne M, Y1 - 2016/03/10/ PY - 2015/08/06/received PY - 2016/02/15/accepted PY - 2016/3/12/entrez PY - 2016/3/12/pubmed PY - 2017/1/7/medline KW - anxiety KW - depression KW - e-therapy KW - feasibility KW - infertility SP - 1046 EP - 57 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 31 IS - 5 N2 - STUDY QUESTION: Is it feasible to evaluate a personalized e-therapy program (Internet based) for women during fertility treatment aimed to reduce the chance of having clinically relevant symptoms of anxiety and/or depression after unsuccessful assisted reproductive technology (ART) treatment within a randomized controlled trial (RCT)? STUDY ANSWER: The evaluation of a personalized e-therapy program is feasible, reflected by good acceptability and integration within current guidelines, but adjustments to the e-therapy program and study design of the RCT have to be made to enhance demand, practicality and efficacy. WHAT IS KNOWN ALREADY: Internet-based interventions are promising in reducing psychological distress, especially when treatment is personalized to specific risk profiles of patients. However in fertility care, the beneficial effects of personalized e-therapy on psychological distress and its implementation in daily clinical care still have to be evaluated. STUDY DESIGN, SIZE, DURATION: To evaluate the feasibility of a personalized e-therapy program, we conducted a two-arm, parallel group, single-blind feasibility randomized controlled trial with a 1:1 allocation. Feasibility was assessed in terms of demand, acceptability, practicality, implementation, integration and limited efficacy. Women were included between 1 February 2011 and 1 June 2013. Women in the control group received care as usual, whereas women in the intervention group received in addition to their usual care access to a personalized e-therapy program. Women were monitored until 3 months after the start of their first ART cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS: In a university hospital in the Netherlands women who were screened as at risk for emotional adjustment problems and intended to start their first ART cycle were invited, and of them 120 were randomized. Of these women, 48% in the intervention group were compliant to the intervention. Outcome measures associated with the feasibility to analyse this e-therapy program within an RCT were assessed. MAIN RESULTS AND THE ROLE OF CHANCE: It is feasible to evaluate a personalized e-therapy program within an RCT. The acceptability was good, as was the integration within current clinical guidelines and care. However, the demand reflected by a participation rate of 44% was low, since most women declined participation because they felt no need for support at that moment. The practicality of the intervention was moderate illustrated by a relatively high dropout rate (30%) due to practical concerns. The intervention was effective, shown by a reduction in the percentage women having clinically relevant symptoms of anxiety and/or depression in the compliant intervention group compared with the control group 3 months after the first ART cycle; risk difference of 24% (95% CI: 2-46%; ITALIC! P = 0.03). LIMITATIONS, REASONS FOR CAUTION: The large non-participation rate (56%) needs further evaluation. This also could have influenced results on limited efficacy. Barriers for participation could be assessed more in-depth. Moreover, ∼30% dropped out. This percentage is comparable with other e-health studies. Finally, this is a single-centre study. Generalizability could be enlarged by a multi-centre approach. WIDER IMPLICATIONS OF THE FINDINGS: In clinical fertility care, personalizing an e-therapy program to the patients' risk profile is promising and feasible. However, in future studies, we recommend modification of the study protocol by for example offering the intervention to the preferred moment in the treatment process. Moreover, adjustment of the study protocol tailored to the found barriers and facilitators is needed. When performing a multi-centre consecutive RCT to assess the effectiveness of personalized e-therapy in fertility care, the findings of this study, for example concerning the preferred timing or reasons for non-participation, could be helpful. STUDY FUNDING/COMPETING INTERESTS: NutsOhra (Study Number 0702-94) funded this study with an unrestricted grant. There were no competing interests. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT 01283607. TRIAL REGISTRATION DATE: 21 January 2011. DATE OF FIRST PATIENT'S ENROLMENT: February, 2011. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/26965429/e_Therapy_to_reduce_emotional_distress_in_women_undergoing_assisted_reproductive_technology__ART_:_a_feasibility_randomized_controlled_trial_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dew040 DB - PRIME DP - Unbound Medicine ER -